Left atrial appendage closure device implantation in patients with prior intracranial hemorrhage.

Background: The Watchman device (Boston Scientific), used for left atrial appendage closure (LAAC), was approved for stroke prevention in patients with atrial fibrillation (AF) and an appropriate rationale to avoid long-term oral anticoagulation. Patients with AF and prior intracranial hemorrhage (ICH) were excluded from clinical trials because of perceived risks of perioperative anticoagulation.

Objective: The purpose of this study was to study the efficacy and safety of LAAC using Watchman in patients with AF and prior ICH.

Methods: In a multidisciplinary AF/stroke prevention clinic, 38 consecutive patients with AF and prior ICH underwent Watchman implantation. Patients were enrolled in a prospectively maintained data registry.

Results: Patients' mean CHADS-VASc score was 5.0 ± 1.3 and HAS-BLED score 4.2 ± 1.0. Prior ICH events were intraparenchymal (60%), subdural (24%), or subarachnoid bleeds (16%). The median event-to-implantation time was 637 days (minimum 60). Watchman was implanted in all patients with no procedural complications. All patients completed 45 days of anticoagulation with warfarin (55%), apixaban (37%), or dabigatran (8%). Transesophageal echocardiograms at 45 days showed no peridevice leak, and 1 patient had a small filamentous echodensity on device that resolved with anticoagulation. While undergoing anticoagulation, none of the patients developed recurrent ICH. Minor bleeding occurred in 1 patient (trauma-related lower extremity hematoma at 19 days postimplantation). At 13.4 months (quartiles 8-19) of follow-up, there were no strokes, ICH, or deaths.

Conclusion: AF patients with prior ICH tolerated short-term anticoagulation for the purpose of Watchman implantation. LAAC with attendant short-term anticoagulation seems to be both safe and effective in this patient population.